PMID- 35816832
OWN - NLM
STAT- MEDLINE
DCOM- 20220830
LR  - 20221101
IS  - 1525-5069 (Electronic)
IS  - 1525-5050 (Linking)
VI  - 134
DP  - 2022 Sep
TI  - The real-world effectiveness and safety of perampanel in Europe: A scoping 
      review.
PG  - 108777
LID - S1525-5050(22)00226-8 [pii]
LID - 10.1016/j.yebeh.2022.108777 [doi]
AB  - In order to characterize the real-world effectiveness and safety of perampanel 
      during clinical use in Europe, we conducted a structured literature search and 
      scoping review of real-world studies conducted in Europe in adolescents 
      (aged >/= 12 years) or adults who were prescribed perampanel for focal epilepsy or 
      primary generalized tonic-clonic seizures in the context of idiopathic 
      generalized epilepsy, published between January 2016 and July 2021. We identified 
      29 relevant studies (20 retrospective and 9 prospective) in 3608 patients; median 
      study duration was 12 months. Most patients (76.1%) were receiving two or more 
      antiseizure drugs (ASDs) when perampanel was initiated. The maintenance 
      perampanel dose ranged from 2 to 16 mg/day (most commonly 6 mg/day). Retention 
      rate at 12 months ranged from 46% to 90.5% (median 71.1%). The proportion of 
      patients who were free of seizures during perampanel ranged from 1.8% to 84.6%, 
      but were consistently below 20% in studies where patients had received an average 
      of >/=5 prior ASDs and above 20% where patients had received an average of <5 prior 
      ASDs. The proportion of patients who achieved >/=50% reduction in seizures during 
      perampanel ranged from 20.0% to 85.7%. Across all studies, the incidence of 
      adverse events (AEs) ranged from 18.2% to 67.4% (median 37.1%) and 
      discontinuation due to AEs from 6.2% to 56% (median 12.5%). Discontinuation rates 
      tended to be higher in UK studies than in studies from Italy or Spain. The most 
      commonly reported individual AEs were dizziness/vertigo (median incidence 13.7%), 
      somnolence (median 11.9%), aggression (median 9.8%), irritability (median 9.1%), 
      and cognitive deficits (median 7.0%). There was no relationship between the 
      overall rate of AEs and perampanel dose, perampanel plasma levels, or number of 
      concomitant medications. Our global overview of European observational studies 
      with perampanel provides evidence that this agent is effective and safe in 
      clinical practice in a range of countries, patients, and settings.
CI  - Copyright (c) 2022 Elsevier Inc. All rights reserved.
FAU - Estevez-Maria, Jose Carlos
AU  - Estevez-Maria JC
AD  - Neurology Department, Hospital Reina Sofia, Cordoba, Spain. Electronic address: 
      josec.estevez.sspa@juntadeandalucia.es.
FAU - Garamendi-Ruiz, Inigo
AU  - Garamendi-Ruiz I
AD  - Epilepsy Unit, Cruces University Hospital, Bilbao, Spain.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20220708
PL  - United States
TA  - Epilepsy Behav
JT  - Epilepsy & behavior : E&B
JID - 100892858
RN  - 0 (Anticonvulsants)
RN  - 0 (Nitriles)
RN  - 0 (Pyridones)
RN  - H821664NPK (perampanel)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - *Anticonvulsants
MH  - Drug Therapy, Combination
MH  - Europe
MH  - Humans
MH  - Nitriles
MH  - Prospective Studies
MH  - *Pyridones
MH  - Retrospective Studies
MH  - Seizures
MH  - Treatment Outcome
OTO - NOTNLM
OT  - AMPA receptor antagonist
OT  - Antiepileptic drugs
OT  - Focal epilepsy
OT  - Idiopathic generalized epilepsy
OT  - Real-world effectiveness
COIS- Declaration of Competing Interest The authors declare the following financial 
      interests/personal relationships which may be considered as potential competing 
      interests: JC Estevez has received consultancy fees from Eisai related to this 
      review, and fees for conferences sponsored by Eisai, Bial, UCB and Esteve. I 
      Garamendi has received consultancy fees from Eisai related to this review, and 
      fees as speaker from Bial, Eisai, Esteve, Livanova and UCB.
EDAT- 2022/07/12 06:00
MHDA- 2022/08/31 06:00
CRDT- 2022/07/11 18:16
PHST- 2022/03/14 00:00 [received]
PHST- 2022/05/27 00:00 [revised]
PHST- 2022/05/29 00:00 [accepted]
PHST- 2022/07/12 06:00 [pubmed]
PHST- 2022/08/31 06:00 [medline]
PHST- 2022/07/11 18:16 [entrez]
AID - S1525-5050(22)00226-8 [pii]
AID - 10.1016/j.yebeh.2022.108777 [doi]
PST - ppublish
SO  - Epilepsy Behav. 2022 Sep;134:108777. doi: 10.1016/j.yebeh.2022.108777. Epub 2022 
      Jul 8.